Related Studies

Overview

This program has been developed to meet the needs of two diverse groups: those in the
pharmaceutical industry who need to upgrade their existing skills and/or acquire new skills and
knowledge in other areas of the industry, and those contemplating a career change who require
relevant knowledge and experience of the pharmaceutical industry. This comprehensive certificate
program covers the major requirements of the pharmaceutical industry and incorporates specific
components to meet the needs of both groups.

This program provides training in pharmaceutical analysis, product formulation, quality
assurance/control and manufacturing, microbiology and toxicology. The practical training provides
students with hands on experience necessary to perform drug assays. Relevant GMP and regulatory
requirements are included.

Note:Students must wear lab coats and safety glasses in every class of all labs. These items can
be purchased at Seneca@York bookstores. No students will be allowed in the labs without lab coats
and safety glasses. Their use is required from the first day of class through to the end of the
semester.

Information Session

New students are invited to attend an information session.

Career Opportunities

Graduates of the Industrial Pharmaceutical Technology Certificate Program may find employment in
the pharmaceutical industry in manufacturing, quality control laboratories, quality assurance,
research and development or validation.

Specialization Offered under IPT Program

Industry Department

Titles Used in Industry

Pharmaceutical
Manufacturing and Validation

Formulation Development
Process Development
Packaging and Production Validation

Graduate Opportunities

For more details on related occupations, job market information and career opportunities, please
visit the
Government of
Canada website.

National Occupational Classification (NOC) - Government of Canada

The
National Occupational Classification
(NOC) provides a standardized language for describing the work performed by Canadians in the
labor market. It gives statisticians, labor market analysts, career counselors, employers and
individual job seekers a consistent way to collect data and describe and understand the nature of
work.

Entry Requirements

Ontario Secondary School Diploma or University/College Preparation: Grade 12 English, Chemistry,
Mathematics and Grade 11 Biology are required. Mature students with work experience are considered
on that basis, but may be advised to take College preparatory Chemistry, English, Biology, and
Math.

Students who hold a diploma or degree from another country and have the above credits may
directly enrol into the IPT program. You do not have to show your documents or write an admission
test.

Prerequisites

It is your responsibility to ensure that program requirements and course prerequisites as
outlined are met. Prerequisites are included for your academic protection. Knowledge of the
prerequisite material is assumed by your instructor and instruction will proceed accordingly.
Students lacking prerequisites not only jeopardize their own ability to succeed but present
unnecessary interruption. If you lack appropriate prerequisites (or Transfer Credit for the
prerequisite course) you may be asked to withdraw or transfer to a more appropriate course with the
risk of academic/financial penalty.

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Curriculum

This course is designed as a continuation of PFT501-Pharmaceutical Manufacturing Methods, teaching advanced pharmaceutical dosage forms in respect to design, development, techniques and technology involved. The processes and methodology involved in manufacturing of different dosage forms are compared in the following perspectives: equipment, benefits and appropriate application. (Lecture only)

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PFT301

Lab Assay Methods I

Availability

This laboratory-oriented course addresses techniques and methods used in pharmaceutical analysis. Pre-lab and post-lab lectures delve into the theory of separative and analytical techniques and include clarification of relevant pharmaceutical terminology. PFT301 also provides an introduction to thin layer chromatography. (Lectures and Labs)

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PFT401

Microbiology I

Availability

This course is designed to teach students the basic methods used in microbiology to identify and enumerate bacteria. Students are introduced to the microbial world through practical experimentation, and acquire the essential tools to function in a laboratory setting. (Lecture and Lab)

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PFT501

Pharmaceutical Manufacturing Methods I

Availability

This course is an introduction to the methods related to the production of pharmaceuticals. Several dosage forms such as solids, liquids, semi-solids, and parenterals are discussed. In each, the merits of the type, composition, handling, processing, testing and equipment used are discussed to provide a foundation from which more specific training can be undertaken. Regulatory requirements which serve as controls, as well as the rationale which support their application are discussed and applied to areas of plant operations. (Lecture only)

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PFT613

Pharmaceutical Chemistry

Availability

Pharmaceutical Chemistry is an area of chemistry focused on synthesis, development, and study of molecules used in medicine and their interactions with biological agents. Topics include organic, inorganic and biochemistry which are an integral part of this course. (Lectures and Labs)

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PFT701

Introduction - Clinical Pharmacology

Availability

This course introduces the fundamental pharmacological aspects of drugs and their interaction with various types of cells. Topics include routes of drug administration, factors affecting drug absorption and mechanism of action. Specific drugs for the central and autonomous nervous systems as well as the cardiocascular system are studied. Drugs for the endocrine system, therapeutic monitoring system and antiallergic, antihistaminic, antiseptic and disinfectants are also covered. (Lecture only)

This course focuses on product development and registration in Canada. Students learn, and get a hands on approach to prepare a high quality clinical trial application (CTA), including generic and brand submissions. Emphasis is made on the mechanics of preparing submissions in the Common Technical Document (CTD) format in Canada. Specifically, this course clarifies the rules, regulations and guidelines on how submissions are prepared, and how deficiency letters are addressed to TPD. An overview of the e-CTD modules is provided in detail. (Lecture only)

This course provides students with a review of the functions and purposes of international harmonization and International Regulatory Affairs. Pharmaceutical regulations in USA, European countries, Japan and MENA region are examined as well as the regulations in a selected number of other geographic locations. Drug submission requirements based regulations in these countries are compared.

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PFT840

A Practical Approach to QA System Design/Managemnt

Availability

This course describes the role and responsibilities of the Quality Assurance department in a pharmaceutical company. A) It focuses on the design of proper quality control/quality assurance systems to ensure the manufacturing of safe products and also to satisfy regulatory authorities. All systems, from cleaning to component testing, from product assay to product release are geared to provide the manufacturer documented quality checkpoints on the product. B) It focuses on the management of the quality assurance systems to provide sufficient and adequate records on all testing distribution and all other procedures that must be in place. (Lecture only)

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PFT860

Qualification of Pharmaceutical Processes & Equip.

Availability

This course is an overview of the various aspects of validations, qualification/validation of pharmaceutical systems, processes and equipment. These processes received acceptance by the pharmaceutical industry in the late 1970s to ensure current Good Manufacturing Practices (cGMP) and product quality and integrity. Reliance upon end-product testing is insufficient to assure product quality. A high degree of quality of assurance arises only from good product and process design, validation and process controls. Validation concepts are applicable to both oral, solid dosage forms and sterile manufacturing pharmaceutical facilities. (Lecture only)

This advanced course focuses on the theoretical and practical aspects of formulation of solid, semi-solid, and liquid pharmaceutical products. New dosage form development is discussed in terms of: New Drug Development and Approval Process; Dosage Form Design; Manufacturing Methods; Development of Stability programs and Revision of old products. Products include lotions, creams, vanishing creams, and ointment bases. (Lecture and Lab only)

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PFT913

Packaging Development II

Availability

This course deals with experimental investigation and evaluation of many kinds of package containers such as glass, plastic, metal and paper, closures, liners, and rubber stoppers. Topics include testing methods, development of quality control methodology, legislative influences on packaging technology, and the role of the package in marketing. (Lecture only)

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PFT926

Basic HP Liquid Chromatography

Availability

This course is an introduction to the theory and practical application of high performance liquid chromatography (HPLC). Students operate an automated HPLC system and learn HPLC theory through lectures and laboratory exercises. Topics cover both qualitative and quantitative aspects of HPLC. (Lectures and Labs)

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PFT930

Industrial Drug Legislation

Availability

Prerequisite(s):

It is strongly recommended that students have basic computer skills as this course requires computer access.

This course examines the organizational role, responsibilities and requirements of the Health Canada related to the production, labelling, selling, and advertising of drugs, radiopharmaceuticals, biologics, natural health products and medical devices in Canada. A review of USA and EU laws and regulations is also covered. (Lecture only)

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PFT955

Contamination Control in Pharmaceutical Manufac.

Availability

This course covers the principles of contamination control in pharmaceutical manufacturing. Topics include: basic microbiology, government regulations related to contamination control, microbial control of contamination in manufacturing, air filtration, ventilation, purification and control of water system and water testing for pharmaceutical manufacturing, production hygiene, employee health and hygiene requirements, microbiological testing of environment and interpretation of critical test results, evaluation of disinfectant and cleaning validation, self inspection and training of production employees for contamination control, preparing for government inspection for compliance related to contamination control. (Lecture only)

Comply with relevant Good Manufacturing Practices (GMP), local as well as international
regulatory requirements and drug legislation

Design a quality assurance (QA) system and apply quality assurance/control measures to
pharmaceutical manufacturing and packaging

Apply knowledge of dosage form to manufacturing and quality control of pharmaceutical
products

Perform as a member of a quality assurance team

Properly use and maintain both a liquid and gas chromatographer

Control contamination during the manufacture of pharmaceutical products

Credit for Prior Learning

Prior Learning Assessment

Earn college credits for what you already know!Prior Learning Assessment is a method of assessing and recognizing learning that is equal to
college level learning, but has been gained outside a traditional classroom (through work
experience, volunteering, outside study, etc.). If you can prove that the knowledge you have gained
meets the outcomes of a Seneca course, then credit will be awarded.

How does the PLA process work?Prior Learning is demonstrated through a "challenge" process. The process measures learning
through a variety of methods which may include tests, portfolio assessment, interviews,
demonstrations, essays, and work samples. The method used will be determined in consultation with a
Program Coordinator.
For more information and to determine if you are eligible for PLA, please call the Program
Coordinator.

The process may take from 6 to 8 weeks.

Note: Not all courses can be challenged. For more information go to
PLA website or contact your
Program Coordinator.

Transfer Credit (Advanced Standing)

Many students who enter Seneca College will have earned academic credits in post-secondary
educational institutions which they may be able to apply toward completion of a Seneca College
program.

Requests for Transfer Credit must be for a specific course and must be accompanied by an
official transcript and course outline. A minimum grade of "C" (60 percent) is generally required
for a course to be considered for Transfer Credit.

Download a
Transfer
Credit Request form. An official copy of your transcript and applicable detailed course
outlines should be attached and submitted. Please note it may take 4 to 6 weeks for a Transfer
Credit decision.

More Information

Graduation

If you meet all program requirements and become eligible for a Certificate, Diploma or Degree
you must inform the Registrar by completing a
Graduation Application
form and paying the fee. Forms are available at the Registration office and online.

Certificates and diplomas are issued twice a year: Fall (October) and Spring (June). Graduation
Application forms must be received no later than July 31 (for Fall Convocation), November 30 or
March 31 (for Spring Convocation).

Minimum Performance for Graduation

Students will only be eligible to graduate with a Seneca College certificate or diploma if they
have maintained an overall good standing in their current program of study. Students in degree
programs will be eligible to graduate when they have obtained an average of C (2.5 GPA) in courses
in the main field of study, and an average of C (2.0 GPA) in all other courses.

Residency Requirements

A Faculty of Seneca College may recommended a student for a certificate, diploma or degree only
after the student has earned a minimum of twenty-five percent of the credit for that program at
Seneca.